1. P15080: Flow Culture System Multi-Disciplinary Senior Design Problem Definition Review September 11, 2014 Collin Burkhart – Lead Mechanical Engineer Katelyn Busse – Lead Biomedical Engineering Michelle Garofalo – Project Manager Robert Repetti – Lead EDGE Facilitator Morgan Stoessel - Treasurer Sarah Tran – Note Taker

2. Agenda ●Project Background ●Project Statement ●Stakeholders ●Use Scenarios ●Customer Needs and Constraints ●Engineering Requirements ●House of Quality ●Benchmarking ●Top Risks ●Deliverables ●Project Plan ●Questions

3. Project Background ●Cell culture o What is it? ●Motivation for this project

4. Problem Statement ●Current Status o 2D - Static o 3D - Static ●Current Limitations o Static Conditions o No current device o Micro vs. Macrofluidics ●The Main Objective

5. Stakeholders ●Dr. Jennifer Bailey ●Biomedical engineering students taking Advanced Cell Culture Class ●Dr. Dan Phillips ●Biomedical Engineering Department ●Rochester Institute of Technology ●MSD Team (and potential future MSD Teams)

6. Communication Plan ●Follow up meeting with Dr. Bailey every two weeks ●E-mail customer with questions and concerns at any time ●Discuss budget with Dr. Phillips ●Reach out to Dr. Man and Dr. Gaborski for endothelial expertise

7. Use Scenario Flow Culture Lab Experiment to Grow Endothelial Cells RIT Instructor Student(s) Advanced Cell Culture class offered Retrieves flow culture system from storage Inspects components for damage Has students perform experiment Assembles components of system Sterilizes empty system in autoclave Transport system to biosafety hood Replaces damaged components Damaged? Yes No

8. Use Scenario Flow Culture Lab Experiment to Grow Endothelial Cells RIT Instructor Student(s) Add sterile media to media reservoir Seed growth plate Add seeded growth plate to growth chamber Transfer to incubator Power pump and sensory equipment Activate pump to initiate media flow Ensure flow is continuous and free of bubbles

9. Use Scenario Flow Culture Lab Experiment to Grow Endothelial Cells RIT Instructor Student(s) Adjust pump flow rate for desired shear stress Adjust incubator for desired pH value Adjust incubator temperature as desired Allow cells to grow Cycle through new media every 3-4 days Disconnect growth chamber to view cells Reconnect growth chamber after viewing

10. Use Scenario Flow Culture Lab Experiment to Grow Endothelial Cells RIT Instructor Student(s) End experiment after two weeks Deactivate pump Cut power to pump and sensory equipment Transfer system to biosafety hood Disconnect growth chamber Drain remaining media from system Observe cells in growth chamber on microscopes

11. Use Scenario Flow Culture Lab Experiment to Grow Endothelial Cells RIT Instructor Student(s) Advanced Cell Culture class ends Students have completed experiment Drain growth chamber Autoclave all equipment Return equipment to instructor Returns equipment to storage Process repeats for additional experiments

12. Customer Requirements Importance: 1=Essential, 2=Customer Want, 3=Preference

13. Essential Customer Requirements Sterility, Temperature, pH

14. Constraints ●It is assumed that the flow culture system will be using only animal endothelial cell lines ●This system may need to sit in an incubator to control temperature, media pH, and relative humidity ●Chamber that holds cells needs to fit on defined microscope stages ●System must be sterilized by autoclave ●Budget of ~$1550

15. Engineering Requirements Importance: 1=Essential, 2=Customer Want, 3=Preference

16. Essential Engineering Requirements

17. Description and Tests

18. House of Quality ●Every customer requirement has been satisfied by at least one engineering requirement. ●Diagram can be found at the following location on EDGE: http://edge.rit.edu/edge/P15080/public/Problem%20Definition%20Documents/Additional%20Docum ents P15080_House_of_Quality document

19. Benchmarking ●Perform cell culture in BME Lab with Dr. Bailey ●Research and contact representatives of current companies that market cell culture flow devices ●Confer with Dr. Gaborski and Dr. Man

20. Top Risks Budget: ●Materials too expensive Schedule: ●Team member delays ●Unexpected labor hours Technical: ●Unable to keep materials sterile ●Material malfunction ●Pump inadequacies ●Lack of knowledge in electrical engineering spectrum for sensor configuration

21. Project Plan

22. Deliverables for Next Cycle ●Functional Decomposition9/18 ●Concept Generation9/23 ●Morph Table9/23 ●Function/Engineering Analysis9/23 ●Feasibility Analysis9/25 ●System Design Review9/30 or 10/2

23. Questions, Comments, or Concerns? Thank you!